Posts Tagged ‘GlaxoSmithKline’

Pfizer writes off $725 million – were they a victim of scientific fraud?

January 20, 2014

Whether it is just error or bad judgement or fraud we will never know. Perhaps all three.

NewsObserver: In 2008, Pfizer paid $725 million for the rights to a Russian cold medicine called Dimebon. The pharmaceutical giant thought the drug could help ameliorate the symptoms of Alzheimer’s. Several clinical trials showed the medicine had no more impact than a placebo. Pfizer has largely abandoned the project.

Earlier this week came the news that Pfizer have now written off the entire $725 million.

The last flickering hope that Medivation’s Dimebon could help Alzheimer’s disease patients has just been extinguished. The biotech announced this morning that a 12-month study of the drug failed to register significant improvements for patients, mirroring two shorter Phase III studies in which Dimebon failed to outperform a sugar pill. Pfizer took the opportunity to bow out of its partnership, writing off its $225 million upfront and $500 million milestone program for what proved to be another embarrassing pipeline failure.

In 2008, Dimebon looked like an odds-on success, with positive data from a Russian study and 10 years of sales experience to underscore its safety. But Medivation was shaken to the core when its first late-stage study ended in failure, with an additional pratfall for Huntington’s disease to cap the disaster.

In the end, Dimebon’s failure helped tarnish the reputation of Russian drug studies while raising severe doubts about Medivation.

It is not only Pfizer which has been forced to make costly write-offs. Not long ago  GlaxoSmithKline was forced to shut down Sirtris Pharmaceuticals which it had acquired in 2008 for $720 million:

Xconomy:

Glaxo paid $720 million to acquire Sirtris in April 2008, to get ahold of technology that generated lots of breathless media coverage as a modern-day fountain of youth. The company sought to make drugs that act on sirtuins, a class of proteins that scientists believe play a role in aging, programmed cell death, and other key cell processes.

Even though the company is closing the Sirtris site, Stubbee says Glaxo remains confident in the drug candidates it got from that acquisition. ….

…. Sirtuins are known to be active when the body is in a calorie-restricted state, which scientists have shown contributes to longer lifespan. The idea at Sirtris was to make small-molecule chemical compounds that activated sirtuins as a way of fighting diseases that develop as people age—including Type 2 diabetes and cancer. ….. The research into the biological role of sirtuins, from Sirtris co-founder David Sinclair, has attracted its share of skeptics. Just last week, Sinclair, a researcher at Harvard Medical School, sought to buttress his early work with a new article in Science that says resveratrol and related compounds can activate sirtuins. One critic, quoted by the Boston Globe last week, said the role of one sirtuin called SIRT1 in aging, “is still as clear as mud.”

GSK is putting a brave face on all of this.

But for many medical and biotech researchers, the path to fame and fortune is by starting a start-up with some new compound or technique and by “leveraging the promise”. For pharma and biotechnology start-ups the objective is to be bought up by one of the majors for as exorbitant an amount as can be managed. And it seems that one way to inflate the value is by making preliminary data and trials show very optimistic results. Negative results never see the light of day and the positive aspects are exaggerated and at worst manipulated.

The ten-fold growth of retractions in medicine related fields since 1975 is mainly due to misconduct according to this report in Nature where “fraud or suspected fraud was responsible for 43% of the retractions”.

For Big Pharma this is simply a consequence of having “outsourced” part of their research. They can afford a few failures it could be thought. Of course the final cost is eventually borne by the consumers but some start-ups make a killing along the way.

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Flu vaccine strongly linked to narcolepsy in children

March 9, 2013

I believe that massive public health programs every winter for the consumption of flu vaccines are driven more by commercial rather than medical considerations. Now comes the news that the risk of narcolepsy in children is enhanced 14 times by the use of Pandemrix. Indiscriminate use of flu vaccines – especially with their limited effectiveness  – do a major public disservice by providing ammunition for the “anti-vaccination brigade”. Whether the success rate of the flu vaccines is high enough to justify the expense of mass campaigns is not clear for me. Certainly I am uncomfortable with the links  between pharmaceutical companies and those who authorise mass campaigns of vaccination.

(Reuters)Growing evidence of a link between GlaxoSmithKline Plc’s pandemic flu vaccine and an increase in narcolepsy cases among children who received it in Europe, is giving pause to health regulators weighing approval of a similar vaccine in the United States.

Data published recently in the British Medical Journal found that children in England who received GSK’s Pandemrix vaccine during the 2009-10 H1N1 swine flu pandemic had a 14-fold heightened risk of developing narcolepsy, a chronic and potentially debilitating sleep disorder that can cause hallucinations, daytime sleepiness and cataplexy, a form of muscle weakness precipitated by strong emotion.

Authors of the study – whose results echo those of similar studies in Sweden, Finland and Ireland – said the data had implications for the approval and use of future vaccines that, like Pandemrix, contain AS03, a new adjuvant, or booster, that turbo-charges the body’s immune response to the vaccine.

Scientists believe AS03 may be the culprit in the narcolepsy cases though they have yet to decipher the precise nature of the association.

…. A 14-member panel of advisors to the FDA voted unanimously in November to recommend the vaccine to protect against bird flu. The panel considered early studies from Europe showing an increase in the number of narcolepsy cases but concluded that the potential benefit of the vaccine outweighed the risk.

Since then, however, new data, including the study results from Britain, suggest the scale and strength of the narcolepsy link could be greater than first thought. At least one committee member would like the FDA to reconvene the panel.

…. According to GSK, some 30 million doses of the vaccine were administered across Europe and 800 people, mostly children, developed narcolepsy. While acknowledging an association, the company says there is insufficient evidence to prove Pandemrix is the cause. ……

I am not sure if the numbers (except the revenues and profits) actually add up.

 

When “science” becomes a marketing tool for pharmaceuticals

December 3, 2012

There are many industries which play the “science as marketing game” but perhaps the most blatant are the pharmaceutical and medical industries. Sometimes researchers are just unwitting pawns in the marketing game but in a sense they are also at fault in being susceptible to becoming pawns. This cautionary tale about the diabetes drug Avandia reported in the Washington Post only enforces my view that since society invests the scientist with an aura of objective truth-seeking, then society must also demand a measure of responsibility and accountability from the scientist. And that can only happen if scientists have a measure of liability for the “product” they produce.

(more…)


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